The Northeast ALS Consortium (NEALS) Data and Safety Monitoring Board (DSMB) recently issued Synapse Biomedical Inc. a notice to suspend amyotrophic lateral sclerosis patient enrolment for a randomized control trial of diaphragm pacing. The suspension of new enrolment was not due to safety concerns, but as a response to the slow rate of patient recruitment and the company’s impending failure to meet the target sample size within the next 6 months.
Interim data analysis was still able to produce positive findings on the NeuRx Diaphragm Pacing System however, and the DSMB has allowed Synapse Biomedical to pursue studying the ALS patients who have already been enrolled and treated. Lead investigators on this research program sent a letter dated September 16 to all study sites, stating the company will be reviewing all findings in 6 months and requesting the DSMB to reconsider lifting the suspension.
“Obviously we are disappointed that enrollment in this study has been this slow, but we are still committed to continuing to study the diaphragm pacing system for ALS patients,” said Anthony Ignagni President/CEO of Synapse Biomedical, “We are confident in the safety and therapeutic utility of DPS when patients are carefully selected and screened according to FDA approved criteria. We will pour our support behind the U.S. Post Approval Study (PAS). The PAS has already surpassed its initial enrollment target and interim data shows a positive benefit for ALS patients. In fact the PAS exceeds the survival results as reported in the IDE pivotal trial with 21 months survival from implant.”
“There is a select group of patients that diaphragm pacing works in and we need to continue to do research in ALS to continue to confirm the results and optimize patient selection.” said Dr. Raymond Onders, co-inventor of the NeuRx DPS and Professor of Surgery, Remen Chair in Surgical Innovation, University Hospitals Cleveland Case Medical Center.
In September 28, 2011, the US Food and Drug Administration approved the NeuRx DPS as a treatment for chronic hypoventilation due to ALS. It is a four-channel, battery-powered neurostimulator with implanted electrodes, effectively delivering electrical stimulation to the muscles and nerves around the diaphragm. Previously completed studies have shown this implant’s ability to induce better sleep and improve patient survival.